Specialist QA

Weil Group, Inc; Puerto Rico; Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Amgen seeks a Quality Assurance professional to support QA program under minimal supervision, performing multiple duties across manufacturing and distribution. The role requires strong collaboration with regulatory agencies and cross-functional teams to ensure compliance and product quality.

Responsibilities include reviewing MPs, approving validation protocols, leading investigations, site audits, and maintaining site quality procedures.

Qualifications

• Doctorate or
• Masters with related experience
• Bachelors with related experience
• Associates with related experience
• High school/GED with related experience

Responsabilités

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Release of sanitary utility systems and NC investigations.
• Own site quality program procedures and change controls.
• Represent QA on NPI team and support facilities/environmental programs.

Connaissances

Project management

Cross-functional leadership

Regulatory interaction

Data analysis

Communication skills

Independent work

Audit leadership

Formation

Doctorate

Masters + 2 years related experience

Bachelors + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Description du poste

SUMMARY

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

FUNCTIONS

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

EDUCATION

• Doctorate OR
• Masters + 2 years of directly related experience OR
• Bachelors + 4 years of directly related experience OR
• Associates + 8 years of directly related experience OR
• High school/GED + 10 years of directly related experience.

COMPETENCIES/SKILLS

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Client Values/Leadership Practices.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*